Designing trials is challenging enough, but training investigators and managing hospitals to properly conduct the studies adds another level of difficulty. Intrabiotics Pharmaceuticals Inc. learned that the hard way, resulting in at least a one-year delay in completion of its Phase III trial of Ramoplanin Oral for the prevention of vancomycin-resistant enterococci (VRE) infections in patients who are immunocompromised due to chemotherapy or bone marrow transplant.

The study, which began in June 2000, has enrolled 104 of a planned 950 patients. IBPI (Mountain View, Calif.) ran into three problems in the trial. First, the logistics of getting oncologists, infectious disease clinicians and microbiology labs to work together at some of the 40 active clinical trial sites was difficult. Second, VRE rates were lower than expected at some hospitals. Third, a